FDA 510(k)

NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI

K-Number: K011125 · 2001-06-13

Decision Date2001-06-13

Product CodeCAT

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Respiratory Care, Inc.. It received FDA 510(k) clearance on 2001-06-13 under 510(k) number K011125. The device is classified under product code CAT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI?

NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI is a medical device that received FDA 510(k) clearance on 2001-06-13. The listed applicant is Hudson Respiratory Care, Inc.. The 510(k) number is K011125.

When did NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI receive FDA 510(k) clearance?

NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI received FDA 510(k) clearance on 2001-06-13, under 510(k) number K011125.

Who is the listed applicant for NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI?

The FDA 510(k) record lists Hudson Respiratory Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI?

The FDA product code for NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI is CAT.

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Other records listing Hudson Respiratory Care, Inc. as applicant

K031383MODEL 780 K011134OXYGEN SUPPLY TUBING, MODEL 1115 K010402SMOOTH-FLO CIRCUIT K001213CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 K994352SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896

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Related Devices (Code: CAT)

K935533NASAL CANNULAPuritas Health Care, Inc.K9223974 SURE TM NASAL OXYGEN CANNULABoston Pacific Medical, Inc.K921496SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIEDAlpine Specialties, Inc.K920573CANNULA NASAL OXYGENB & F Medical Products, Inc.K913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589Specialty Packaging Producs, Inc.K912197SKIN SAVER(TM) TUBING HOLDER, MODEL 467Alpine Specialties, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.